The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Non Invasive Blood Pressure (nibp) Device.
| Device ID | K093907 |
| 510k Number | K093907 |
| Device Name: | WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Huy Doan |
| Correspondent | Jay Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-04-14 |
| Summary: | summary |